Angiography-Derived Physiological Indices for Outcome Prediction in Patients Undergoing OCT-Guided PCI

NCT07511231 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Anzhen Hospital

Phase

Observational

Started

2026-04

Last updated

2026-04-06

Condition(s) studied

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Investigational drug(s) / intervention(s)

OCT-guided PCI

OCT-guided PCI: Not applicable as assigned study interventions. This is an observational study. OCT-guided PCI will be performed according to routine clinical practice at each participating center. Coronary angiographic images obtained before and after PCI will be used to derive angiography-based physiologic indices, including pre-PCI pullback pressure gradient (PPG) and post-PCI Angio-FFR and Angio-IMR, for physiologic characterization and outcome analysis.

Study summary

The primary design of this study is an ambispective observational cohort study. In patients undergoing successful optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with post-procedural angiographic images suitable for computational analysis, this study aims to evaluate the prognostic value of post-PCI angiography-derived physiological indices, specifically angiography-derived fractional flow reserve (Angio-FFR) and angiography-derived index of microcirculatory resistance (Angio-IMR), beyond conventional clinical risk factors and OCT-derived anatomical parameters. Specifically, the objectives are:

1. To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up.
2. To evaluate the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR when added to models incorporating baseline clinical characteristics and OCT-derived anatomical parameters for predicting MACE.
3. To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.

Eligibility

Sex

ALL

Min age

18 Years

Max age

84 Years

Healthy volunteers

Inclusion Criteria:-1.Age \>= 18 years and \< 85 years. 2.Successful stent implantation under OCT guidance. 3.Availability of at least two optimal post-PCI angiographic projections separated by \> 25 degrees and suitable for angiography-derived physiological analysis. \- Exclusion Criteria:1.PCI of the culprit vessel for ST-segment elevation myocardial infarction (STEMI). 2.Cardiogenic shock or requirement for mechanical circulatory support. 3.Life expectancy of less than 1 year. 4.History of coronary artery bypass grafting (CABG). 5.Balloon angioplasty without stent implantation. 6.Severe procedural complications, including intraprocedural death, emergency CABG, or coronary perforation. 7.Target-vessel diameter \< 2.5 mm. 8.Heart failure with New York Heart Association (NYHA) class III-IV symptoms or left ventricular ejection fraction (LVEF) \< 30%. \-

Primary outcome measure(s)

Major Adverse Cardiovascular Events — Up to 24 months after the index PCI
MACE is defined as the first occurrence of any of the following events: all-cause death, spontaneous target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, hospitalization for unstable angina, or hospitalization for heart failure.

Trial sites (1)

Facility	City	Region	Status
Beijing Anzhen Hospital, Capital Medical University	Beijing	China

More Beijing Anzhen Hospital trials in China

China Extracorporeal Life Support Registry Recruiting

A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment Recruiting

Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter Recruiting

The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study (SLEEP-CMD) Starting soon

Target-Oriented Strategy of Ultra-Low LDL-C (<1.0 vs. 1.0-1.39 mmol/L) in Extreme-High-Risk ASCVD Patients: Clinical Benefit, Safety and Cost-Effectiveness Assessment Starting soon

Other trials for the same condition

Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease(CMI-RiskCAD) Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511231 on ClinicalTrials.gov ↗ ← All trials in China